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The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.

Routine Inspections Suspended During Partial FDA Shutdown

Some of the FDA’s regulatory and compliance activities — including routine inspections — were placed on hold because of the partial government shutdown that began on Dec. 22 and continued into the new year.

Almost 60 percent of the FDA’s workforce was kept on to handle core agency activities including high-risk medical product recalls, certain criminal and civil investigations, medical product screening and other critical public health activities.

FDA Commissioner Scott Gottlieb took to Twitter to assure the public the FDA’s core public-health functions continued during the shutdown.